NCT05510037

Brief Summary

About a half of HER2-negative breast cancer show HER2-low expression that can be targeted by new antibody-drug conjugates. The main aim of this study is to describe the evolution of HER2 expression from primary BC to relapse by including HER2-low category in both primary and recurrent BC samples. Patients with matched primary and relapse BC samples were included. 1299 patients were included.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,299

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 22, 2022

Completed
Last Updated

August 22, 2022

Status Verified

August 1, 2022

Enrollment Period

1.4 years

First QC Date

August 15, 2022

Last Update Submit

August 19, 2022

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • overall survival

    The overall survival (OS) was defined as time from the date of initial diagnosis of recurrent/metastatic disease to the date of death from any cause

    up to 200 months

Study Arms (3)

HER2-0

Other: no intervention

HER2-LOW

Other: no intervention

HER2-POSITIVE

Other: no intervention

Interventions

no interventionOTHER

no intervention was needed

HER2-0HER2-LOWHER2-POSITIVE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with available HER2 status of primary breast cancer and relapse/metastases

You may qualify if:

  • Patients with available HER2 status of primary breast cancer and relapse/metastases

You may not qualify if:

  • Patients with other malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Jian Zhang, PHD

    Fudan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the phase I clinical trial department

Study Record Dates

First Submitted

August 15, 2022

First Posted

August 22, 2022

Study Start

January 1, 2021

Primary Completion

June 1, 2022

Study Completion

June 1, 2022

Last Updated

August 22, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)